“If you have a novel technology, come! If you have a me-too product, stay home, said Kirk Zeller, who facilitates launches in Japan and other international markets, at his 10x Medical Device Conference talk in May.

Kirk briefly touched upon subjects that usually make for an hour-long presentation. Click to hear about the Japanese regulatory climate, changes in procedures to commercialize, and what you should know about doing business with distributors in Japan.

“If you’re developing a device and it doesn’t integrate some kind of intelligence, you are contributing to the problem,” began Spyro Mousses, PhD, Co-founder and President of Systems Imagination, at his 10x Medical Device Conference talk in May.

Dr. Mousses explained we need to transform your data into something useful, which is less likely if it doesn’t feed into an expert system or cognitive computing / machine learning system. It’s so impractical to consider data from each system independently that we don’t even collect it.

But “the little taste we’ve gotten from using genomic data to position cancer drugs, to using integrated image analysis, to look at cardiology, has taught us there is a massive amount of intelligence to individualize treatments.”

This will revolutionize healthcare. Watch the video and get the slides below.

I recognize few Medical Devices Group readers have a Siemens-sized budget, but if you are in medical device marketing or compete in Siemens categories, you won’t want to miss this presentation from Francisco Miguel Trigueiros, Managing Director of Global Product Marketing at Siemens Healthineers.

Gary Cohen, Sr. Director Software Center of Excellence at Dexcom, gave us a glimpse how Dexcom won the labeling change that allows them to claim “The Dexcom G5 is FDA-cleared and lets you monitor without pricking your finger.”

What kind of capital should I raise?
• Talk to angels, friends, and family; after that stage get an advisor who will guide you. Another: Go to VCs when you are pre-revenue and seriously consider debt once you’re post revenue so you don’t dilute your ownership.

Is there such a thing as “bad money?”
• Yes. That’s when you end up with a partner you can’t tolerate. Find money that wants to work with you and that understands what it takes to succeed in medical devices. Better still if they are connected in the industry and can make introductions for you.

How do investors determine how risky an investment is?
• They evaluate the management, engineering and regulatory expertise, size of market and financials, the strength of your IP, your freedom to operate, and reimbursement.

Rick added: Whenever you’re raising capital ask yourself, “How much do I need? Why do I need it? How will I pay it back?” And, “The day you get the check is the day you start the next round.”

Dr. Chris Sasiela gave you a gift at this year’s 10x Medical Device Conference: A list of resources from the National Institute of Health (NIH) and their Small Business and Innovative Research (SBIR) program you may have overlooked.

NIH resources are extensive and include:

• Up to $225,000 for your feasibility study and up to $5 million for companies creating FDA-regulated technologies
• $100 million in grants each year for small business research from the NHLBI (National Heart, Lungs, and Blood Institute)
• $800 million across all the divisions of the NIH annually
• Advisors specializing in regulatory, small business, business development, investments, entrepreneurship, and many types of scientific advisors
• A clinical specimen and data repository where you can leverage their clinical studies to validate your diagnostic
• A video library including one clip about how to write an effective grant
• Innovations created in academic labs that you might be able to incorporate into your company
• Innovation conferences where they put you in front of a room of investors plus partnering with other forums

In his insightful 10x Medical Device Conference talk, Dr. Joseph Gulfo explained the official FDA mandate: To promote the public health by PROMPTLY and EFFICIENTLY reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner… protect[ing] the public health by ensuring… reasonable assurance of the safety and effectiveness of devices intended for human use….

But Gulfo says FDA is no longer content approving safe and effective drugs and devices with pre-approval requirements skyrocketing. We need to use our voices to get FDA back to focusing on safety and effectiveness and letting the market decide the clinical utility and winning products.

I asked veteran medical device recruiter Legacy MedSearch CEO Paula Rutledge about the state of hiring in medtech and she said, “It’s great if you are a candidate, not so great if you are a hiring manager.”

As of May 2017, unemployment for SIC codes 3840 and 3841 is less than three percent for ages 25-64 (excludes non-college graduates). Paula says the more experience you have, the more difficult it is to find a great job. So you’ve got to be proactive: Reach out to your network, and invest in a professionally done and keyword-rich resume.

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